Member Info for B2HS2L

My feeling is the market is happy / not happy about the cash position / funding,

dependent upon whether a CLN payment is due.

A few deals signed up, would mean the same thing happening at higher sp levels.

Appointment of Dr.Christina Coughlin as a consultant - 20 September 2023 - Does not mention Diagnostics

AS commented:

"...We are now moving from a phase of building our clinical development capabilities to leveraging that capacity across multiple programmes.

It is therefore appropriate that we transition the Senior Leadership team to incorporate medical oncology experience.

We are fortunate to have the opportunity to benefit in the near term from Christina's immense experience during this exciting period as we seek to appoint a full-time Chief Medical Officer."

Issue of Equity and Total Voting Rights - 23 October 2023 - Diagnostics and Therapeutics associated clearly with Affimers.

Avacta has two divisions: an oncology biotech division harnessing proprietary therapeutic platforms to develop novel, highly targeted cancer drugs, and a diagnostics division, which is executing on an M&A led growth strategy to create a full-spectrum diagnostics business focused on supporting healthcare professionals and broadening access to testing.

Avacta's two proprietary platforms, Affimer® and pre|CISION? underpin its cancer therapeutics whilst the diagnostics division leverages the Affimer® platform to drive competitive advantage in its markets.

Appointment of Chief Business Officer - 19 December 2023 - licensing for pre|CISIONTM *AND* Affimer® platforms

"These emerging data give us, for the first time, the opportunity to accelerate ongoing discussions as well as to generate new opportunities through our business development activities aimed at delivering licensing opportunities for the pre|CISIONTM and Affimer® platforms."

Appointment of Christina Coughlin - 19 January 2024 - Mentions pre|CISION? but not Affimers.

Dr Alastair Smith, Chief Executive of Avacta Group commented:

"The outstanding safety data from the AVA6000 clinical study that we recently presented validates the pre|CISION? platform's ability to deliver cancer drugs specifically to the tumour microenvironment."

+++

On balance, Dx to remain IMO, despite a few recent off the cuff comments recently to the contrary

Looked through various RNS's in last two years, - do they specifically make the case for retaining the

Diagnostics division, or have incoming specialists decided Diagnostics is not the way forward, so generate funds selling Dx?

Proposed acquisition of Launch Diagnostics - 18 October 2022 - significant diagnostic commercial opportunity presumably just as large now.

The Acquisition is the first step in a M&A-led growth strategy by Avacta for its diagnostics division, with the vision of building an integrated and differentiated IVD business with global reach serving professionals and consumers.

The Company believes that there is a significant commercial opportunity in the EU and the UK markets, which are fragmented, to build its position in the immunodiagnostics and molecular diagnostics value chain by acquiring companies that are complementary to Avacta's core strengths in research and development.

Avacta acquires Coris Bioconcept - 01 June 2023 - *Both divisions mentioned*

Avacta appoints Shaun Chilton as Non-executive Director - 19 June 2023

AS commented:

"He brings deep and extensive commercial experience to further strengthen the senior leadership of the Group as it executes its strategy across two divisions to build a major global healthcare business working to improve people's health and well-being through innovative oncology drugs and powerful diagnostics."

Statement regarding market speculation - 19 Jun 2023 - *Diagnostics and Therapeutics still relevant to AVCT*

Avacta, a life sciences company developing innovative, targeted oncology drugs and powerful diagnostics, notes the recent market speculation regarding a possible fundraising...

...The Therapeutics division of the Company continues to make good progress in the Phase 1 clinical trial of AVA6000, its lead pre|CISIONTM targeted chemotherapy, having initiated dosing in the fifth cohort in April and its Diagnostics division recently completed the second acquisition of its buy and build strategy.

As an aside, I'm not sure Pfizer is one of the deal favoutites here, they're surely committed to ADC's :

Source: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-invests-43-billion-battle-cancer

Pfizer Invests $43 Billion to Battle Cancer - Monday, March 13, 2023

"“Pfizer is deploying its financial resources to advance the battle against cancer, a leading cause of death worldwide with a significant impact on public health,” said Dr. Albert Bourla, Pfizer Chairman and Chief Executive Officer. “Together, Pfizer and Seagen seek to accelerate the next generation of cancer breakthroughs and bring new solutions to patients by combining the power of Seagen’s antibody-drug conjugate (ADC) technology with the scale and strength of Pfizer’s capabilities and expertise."

+++

It would seem 'more than $10 billion in risk-adjusted revenues in 2030' will now be optimistic if pre|CISION trial results and a subsequent launch continues to schedule.

FWIW Myles McNulty had this to say (references not available) last year about ADC's:

ADCs are significantly more targeted, and have a higher efficacy, than conventional chemotherapies.

However, the class of therapy nevertheless comes with several major challenges:

- Unavoidable side effects

Severe side effects (grade 3 or higher) are common with ADCs. The most notable are:

i) blood toxicity, including neutropenia, thrombocytopenia, leukopenia, and anaemia;

ii) hepatotoxicity (i.e. chemical-driven liver damage);

iii) gastrointestinal reaction (including nausea, vomiting, diarrhoea, abdominal cramps).

These three types of side effect are all believed to be related to premature release of cytotoxic payloads

in the blood circulation.

iv) nephrotoxicity (i.e. toxicity in the kidneys). This can be caused by the immune response

induced by the antibody component of the ADC.

v) interstitial lung disease (‘ILD’). Whilst it remains unclear, it has been speculated that ILD

might be associated with the uptake of the ADC in healthy lung cells, and the subsequent

payload release from the ADC. [The lungs enjoy abundant blood flow and long retention –

more so than other organs – and as such, are more under threat from undesirable uptake of

ADCs.]

So perhaps Avacta is likely to be involved in some way with HOX Therapeutics Ltd.

That might make Fiona's decision a little more understandable to Avacta and it's shareholders.

+++

Thanks Fiona for all your hard work, you played a big part in allowing AS to state as part of this RNS:

"The outstanding safety data from the AVA6000 clinical study that we recently presented validates the pre|CISION? platform's ability to deliver cancer drugs specifically to the tumour microenvironment. This opens up tremendous opportunities to develop truly innovative cancer medicines that improve outcomes for patients and grow shareholder value."

This is partly the reason for Fiona's decision about her future:

Source Linkedin

Dr Fiona McLaughlin

HOX Therapeutics Ltd

NED

HOX Therapeutics Ltd · Part-time

Dec 2023 - Present · 2 mos

Hybrid

https://www.hoxtherapeutics.com/

Designing new therapies for cancer

Hox is a preclinical-stage biotechnology company focused on the discovery and development of novel, targeted medicines for the treatment of cancer.

Our scientific approach is based on targeting two different tumour-driving mechanisms

+++

Hox Genes

A set of genes that play key roles in defining the identity of cells and tissues in early development and which therefore also have important regulatory roles in cell proliferation and survival.

Our innovation focuses on inhibiting the binding of Hox proteins to PBX thereby overcoming the need to target every Hox protein.

+++

Androgen receptor

Signalling through this receptor is critical for prostate cancer development and progression, but inevitably resistance mechanisms evolve to current therapies.

He also appears in this 02/10/17 RNS:

Avacta establishes US business development team

Avacta appoints three business development executives in US including industry veteran as Vice President of Therapeutics Business Development

https://avacta.com/avacta-establishes-us-business-development-team/

Dr Vincent in the past has been employed at Avacta as VP Business Development and Strategy, before moving on to Point Bio as Senior Vice President, Business Development.

If you look at his experience at both companies on Linkedin: https://www.linkedin.com/in/matthewvincent/ - his employment by PointBio has ended.

Resident in America, it remains to be seen if he finds employment with Eli Lilly.

With this many contacts, and deep understanding of Affimers and both Avcta and PointBio's management, operations and R&D, I would be mildly surprised if he did not find himself working with Affimers at Avacta again soon.

Absolutely right, but this is what happens to yes men when JW changes his project priorities.

I only see JW deciding the agenda, and JM installed to watch the pennies, and progress JW's plans.

Now the CFO role has been re-assigned, and he has not been confirmed in the CEO role,

IMO he is holding the fort until JW finds an opportunity (such as JV or M&A) to confirm the CEO position.

Just My 2c

07.01.2024 - Isomorphic inks deals with Eli Lilly and Novartis for drug discovery

https://techcrunch.com/2024/01/07/isomorphic-inks-deals-with-eli-lilly-and-novartis-for-drug-discovery/

No timescales mentioned for any AI projects. 😕

With the accent on 'accelerate ONGOING discussions', ie accelerate present discussions.

Interested parties or Avacta or both have been using the Q4 23 as a milestone to gauge further interest.

The data did not disappoint A S or F McL, so I assume the new Chief Business Officer will have a full diary for months ahead.

I'm surprised they didn't fill the post earlier.

Viking -

ADC use is prone to a side effect - Interstitial lung disease.

I'm not clear how prone.

2023 source: https://pubmed.ncbi.nlm.nih.gov/37331827/

Diagnosis and management of interstitial lung disease induced by antibody-drug conjugates in breast cancer:

"Abstract

Interstitial lung disease (ILD) has been reported with many cancer drugs including some recent antibody-drug conjugates (ADCs). The mechanisms of ILD induced by many chemotherapy drugs, other drug classes and ADCs used in cancer, including breast cancer, are not clearly elucidated. In the absence of specific clinical or radiological signs, the diagnosis of drug-induced ILD is often a diagnosis of exclusion. When present, the most frequent symptoms are respiratory signs (cough, dyspnea, chest pain) and general signs (fatigue, fever). Any suspicion of ILD should be evaluated by imaging and, if in doubt, the CT scan should be evaluated by a pulmonologist and a radiologist. A network of multidisciplinary experts for proactive early management of ILD is important, including oncologist, radiologist, pulmonologist, infectious disease specialist and nurses. Patient education is essential to report new or exacerbated lung symptoms and prevent high-grade ILD."

Look at the cost of care in the above when ILD results from ADC use.

It's clear to me medical insurers would not want that extra complication.

Acknowledgments

The affimer was produced and supplied by Avacta Life Sciences, Wetherby, UK.

I hoped I would see this acknowledgment, but wasn't sure it would appear.

I wonder how many Scientists and Clinicians know affimers can only be supplied from this source.

FYI - Jan 8th 2024

As cancer players jump head-first into ADC field, Novartis CEO explains how he's resisted the temptation

https://www.fiercepharma.com/premium/webinar/unleashing-ai-opportunities-strong-data-foundation

The Cohort 3 patient with 65% tumour reduction isn't going to need a Non-Disclosure Agreement should their tumour reduction = 100%.

Conversely Avacta might like to have their say in how that situation occurred, when and if it occurs.

All pie in the sky just yet, but if it happens it will make the recent ITV programs concerning the Post Office computer system look small beer in comparison.

Just use the filter facility.

I've been doing it successfully for a year, as he's no research to share.

Saves a lot of typing about an idiot and the accompanying blood pressure.

Cj62 -

IMO it is an easy thing to do to red ring a set of data that looks essentially complete, and wait until further data is collected and analysed, to understand whether the red ringed data does, or does not, form part of a subsequent data set.

Effectively, - how long is a piece of string?

I know that has happened in areas where I have worked. 😉

Buena Vista - Ref your 09:16 post and AVA027:

"AVA027 - PD-L1 Affimer® / TGF? Trap Bispecific (listed in pipeline at end of July 2021)"

RNS 30th Sep 2021 - Interim Results for the Period Ended 30 June 2021 contains an update for this study.

The two lead programmes are AVA027, a PD-L1/TGF- receptor trap combination, and AVA028, a PD-L1/IL2 bispecific.

***As a result of the clinical data from Merck KGaA and their Bintrafusp alfa (a dual TGF-beta/PD-L1 inhibitor antibody), the Company has decided to pause the AVA027 programme.

This will afford the Company time to further understand the issues arising in the Bintrafusp alfa clinical trials and whether they are related to the trial design, and can therefore potentially be dealt with by better trial design, or whether there is a more fundamental issue with this bispecific combination. ***

In the meantime, the Company is using this pause to focus resources on AVA028 to deliver an Affimer® development candidate as quickly as possible."

++++

There are no references for AVA027 beyond this RNS.

I assume that why its missing from the pipeline at https://avacta.com/therapeutics/pipeline/

Response to Thorno 09:20 post.

From Appointment of Chief Business Officer 19 Dec 2023 RNS:

Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented:

"As Chief Business Officer, Simon will work closely with the senior management team and lead commercial strategy and business development activities at this exciting period in the Company's development as compelling clinical data emerges from the AVA6000 phase 1 trial."

"These emerging data give us, for the first time, the opportunity to accelerate ongoing discussions as well as to generate new opportunities through our business development activities aimed at delivering licensing opportunities for the pre|CISIONTM and Affimer® platforms."

Dr Simon Bennett, Chief Business Officer, Avacta Therapeutics commented:

"Avacta is at a pivotal point, having recently announced clinical data that have already begun to generate interest from potential commercial partners. I am delighted to be joining at such an exciting point in the journey of the business, to help the team optimise the commercial opportunities of their technologies and assets."

+++

AS and Simon Bennett laying out the near term Avacta future. - AS's words Thorno/Eggy.

The target being Licensing deals, which will assist in dispelling any medium term financial concerns.

I note Simon uses the word optimise.

Sounds like there are a significant number of commercial opportunities Simon and team need to address, weeding out those that are or become not so attractive, and 'optimising' those with more promise.

Jive_turkey - ref confusion.

This what I have in my notes, with the reference details:

I hope it helps.

AVA028 combines an Affimer PD-L1 antagonist with IL-2 which is a cytokine that plays a signalling role in expanding the number of activated immune cells (T and NK cells). - source Avacta website.

AVA032 - our anti-PD-L1 Affimer® fused to the pro-inflammatory cytokine interleukin 15 (IL-15), displays encouraging efficacy when tested in multiple models of immunomodulation, stimulating a potent immune response and reversing the immunosuppressive tumour microenvironment. - source 05.10.2023 RNS